University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6J4P9, Canada
NCT Number: NCT02499939
The primary purpose of the trial is to determine the preliminary efficacy of therapeutic ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced peripheral neuropathy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6J4P9, Canada
Thirty cancer patients with colon or colorectal cancer undergoing chemotherapy treatment including the agent oxaliplatin will take part in the study. Patients will be randomly assigned to either standard care alone (education and therapeutic exercises) or standard care plus 10 treatments of therapeutic ultrasound to the toes and fingers.
Participants in both groups will follow a home exercise program for a 6 week period. Therapeutic ultrasound will be administered daily (e.g., Monday to Friday) over the first two week period of the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Education and home exercises
Ultrasound is a therapeutic modality that is used by physical therapists to help reduce local tissue pain and inflammation. Ultrasound is applied using a round-headed wand or probe that is placed in direct contact with the patient's skin. Ultrasound gel is used on all surfaces of the ultrasound head to reduce friction and assist in the transmission of the ultrasonic waves. For the purposes of treatment for CIPN, the ultrasound will be applied for 5 minutes to each limb (right toes, left toes, right fingers, left fingers) at frequency of 3.0 megahertz (MHz) and an intensity of 0.7-0.8 watts per cm2.
(For CIPN, the ultrasound will be administered at a lower intensity in order to avoid a heating effect on the tissues.)
Time frame: 6 weeks
Change in pain and sensory disturbance
Time frame: 6 weeks
Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury
Time frame: 6 weeks
Change in protective sensation: using a 10g monofilament for the feet and 6g for the hands to determine presence or absence of protective sensation.
Time frame: 6 weeks
Change in temperature sensation: hot and cold test tubes will be applied to the feet and hands to determine ability to distinguish hot and cold sensations.
Time frame: 6 weeks
Change in vibration sensation: A 128 Hz tuning fork will be applied to the big toe, medial malleolus, thumb and ulnar styloid to determine presence/ absence of vibration sensation.
Time frame: 6 weeks
Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex
Time frame: 6 weeks
Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.
Margie McNeely
Other
Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial
Acronym: ULTRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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